An observational study in Long-term Effects of Cancer Treatment, sponsored by Chen Xiaoping. Completed at 1 site in China. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-11.
Sponsored by Chen Xiaoping · Observational
The investigators established three prospective cohorts of patients with BCLC stage 0-A HCC, based on different surgical approaches (open, laparoscopic and robotic). After 5 years of follow-up, the investigators used propensity score matching (PSM) to reduce selection bias and then compared the long-term oncological outcomes of the three different surgical approaches, which might provide high-level evidence in non-randomized observational studies.
In this study, three prospective cohorts of patients with BCLC stage 0-A HCC, underwent complete liver resection using different surgical approaches (OLR, LLR, and RALR), were established. After adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (PSM) analysis.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's enrollment of 369 is above the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Chen Xiaoping is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
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1669 cases underwent liver resection from July 1st 2015 to June 30th 2017 in Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, including 186 RALR, 527 LLR, and 956 OLR. Among these patients, there were 102, 333, and 669 HCC patients, respectively. Ten patients were excluded due to missing data or follow-up. Finally, 369 HCC patients in the early stages were included in the analysis. After PSM, 168 patients were matched and there were 56 patients in each group
Exclusion Criteria:
In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 71 HCC patients were included in robotic liver resection cohort.
Procedure: liver resection
In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 141 HCC patients were included in laparoscopic liver resection cohort.
Procedure: liver resection
In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 157 HCC patients were included in open liver resection cohort.
Procedure: liver resection
After adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (PSM) analysis.
Overall Survival
The primary outcomes of this study included long-term oncological outcomes of OS
Time frame: 14/02/2015-30/06/2021
Disease free Survival
The primary outcomes of this study included long-term oncological outcomes of DFS
Time frame: 14/02/2015-30/06/2021
postoperative complications
Postoperative morbidity and mortality were assessed according to the Clavien-Dindo classification
Time frame: 14/02/2015-30/06/2021
Textbook Outcome in liver surgery (TOLS)
Textbook Outcome in liver surgery (TOLS), was defined as the absence of intraoperative incidents of grade 2 or higher, postoperative bile leak grade B or C, severe postoperative complications, readmission within 30 days after discharge, in-hospital mortality, and the presence of R0 resection margin.
Time frame: 14/02/2015-30/06/2021
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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